Lead QA Hardware V&V Engineer
Lead QA Hardware V&V Engineer Location: Framingham, MA Duration: 6 months (potential contract to hire) The Quality Assurance hardware verification and validation engineer leads the delivery of verification services to complex firmware / embedded software application and hardware products. This role works with the engineering team to deliver the verification service in accordance with our defined quality system. Ensure that products are tested in adherence to the applicable regulation (FDA/ISO13485) and best practices. This position is the lead QA contact on a project, although there will be significant hands on work required. The QA Lead shall mentor less senior Associates. Responsibilities include leading hardware projects, as well as developing strong partnerships with other technical resources (PM, Engineers, Systems and Support resources). This position may act as an escalation contact for issues regarding project requirements, scope, schedule, progress, implementation planning and product support. Additional responsibilities include project resource forecasting, project time accounting, project budget and project cost planning for provided QA services. This position is responsible for ensuring all QA project deliverables adhere to the appropriate FDA and EU regulatory requirements for medical devices (PLL Test System, PMCC 204, ISO13485, 60601-1, 60068 and 62304) and any Field Correction Orders issued are managed and resolved. Recognition and understanding of international business, technology and customer domains is also necessary. MAJOR RESPONSIBILITIES : QA service lifecycle; plan, realize, deliver, and own Participate with establishing standards on Design Verification and Validation (V&V) processes and tools Participate and provide feedback within the Risk Management reviews Develop knowledge of engineering hardware (Motiva Set Top Box, Communicators, (Wireless, POTS and Cellular), Alert Buttons (Wireless and Cellular)) and business functions within and across these domains (Sales, Customer Care, Product Innovation, and Quality & Regulatory) to facilitate cross-functional opportunities and best practices. Influences and directs engineers and project team to follow the defined procedures within the quality system Provide innovative leadership in acquisition or implementation of improved QA techniques and tools Prepare detailed schedules with Client dates for deliverables, prioritizes and monitors activities to meet such dates, make commitments on delivery Tracks actual progress against schedule and manages resources to meet schedule Use quantitative estimating techniques base on industry practice and personal experience * Uses metrics to collect quantitative project data Lead the project team to develop better development process on firmware and embedded software Develop an in-depth understanding of assigned applications, databases and infrastructure Contributes to product design for compliance with functional and technical specifications as well as customer satisfaction Applies ingenuity and determination to find the best possible options to support business needs Develops overall quality assurance strategy for the project and documents this in the Master Test Plan Creates test strategies that increase test coverage, validate scalability, failover and recovers and improves quality Defines and documents test cases to exercise the product to reveal potential defects Supports environmental testing, Standards testing and usability testing Maintains real time log of executed tests, results and environment Designs and implements automated tests using tools validated within the QA team
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